Trial Outcomes & Findings for The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects (NCT NCT02372630)
NCT ID: NCT02372630
Last Updated: 2023-02-21
Results Overview
JNK-1 protein in MNC before and after linagliptin use as compared to placebo.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Week 0, Week 2, Week 4, Week 12
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
Placebo
Patients will be treated for 12 weeks with placebo once daily
Placebo
|
Linagliptin 5mg Per Day
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Linagliptin
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Patients will be treated for 12 weeks with placebo once daily
Placebo
|
Linagliptin 5mg Per Day
n=20 Participants
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Linagliptin
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 10 • n=20 Participants
|
60.8 years
STANDARD_DEVIATION 8.3 • n=20 Participants
|
59.85 years
STANDARD_DEVIATION 9.15 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
|
BMI
|
37.6 kg/m²
STANDARD_DEVIATION 6.9 • n=20 Participants
|
34.6 kg/m²
STANDARD_DEVIATION 4.8 • n=20 Participants
|
36.1 kg/m²
STANDARD_DEVIATION 5.85 • n=40 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 2, Week 4, Week 12JNK-1 protein in MNC before and after linagliptin use as compared to placebo.
Outcome measures
| Measure |
Placebo
n=17 Participants
Patients will be treated for 12 weeks with placebo once daily
Placebo
|
Linagliptin 5mg Per Day
n=17 Participants
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Linagliptin
|
|---|---|---|
|
JNK-1 Protein in MNC
Week 0
|
0.943 Arbitrary Units
Standard Error 0.148
|
0.801 Arbitrary Units
Standard Error 0.129
|
|
JNK-1 Protein in MNC
Week 2
|
1.106 Arbitrary Units
Standard Error 0.214
|
0.789 Arbitrary Units
Standard Error 0.101
|
|
JNK-1 Protein in MNC
Week 4
|
1.933 Arbitrary Units
Standard Error 0.204
|
0.702 Arbitrary Units
Standard Error 0.102
|
|
JNK-1 Protein in MNC
Week 12
|
0.939 Arbitrary Units
Standard Error 0.123
|
0.550 Arbitrary Units
Standard Error 0.074
|
SECONDARY outcome
Timeframe: Week 0, Week 2, Week 4, Week 12Comparing IL-1B between Linagliptin group and placebo group based on the PCR test, between week 0 and week 12.
Outcome measures
| Measure |
Placebo
n=17 Participants
Patients will be treated for 12 weeks with placebo once daily
Placebo
|
Linagliptin 5mg Per Day
n=17 Participants
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Linagliptin
|
|---|---|---|
|
IL-1β mRNA Levels
Week 4
|
0.736 Arbitrary Units
Standard Error 0.144
|
1.063 Arbitrary Units
Standard Error 0.227
|
|
IL-1β mRNA Levels
Week 12
|
0.811 Arbitrary Units
Standard Error 0.196
|
0.870 Arbitrary Units
Standard Error 0.252
|
|
IL-1β mRNA Levels
Week 0
|
0.768 Arbitrary Units
Standard Error 0.161
|
1.276 Arbitrary Units
Standard Error 0.267
|
|
IL-1β mRNA Levels
Week 2
|
0.885 Arbitrary Units
Standard Error 0.210
|
1.166 Arbitrary Units
Standard Error 0.240
|
SECONDARY outcome
Timeframe: Week 0, Week 2, Week 4, Week 12oxidative stress (ROS generation level) following linagliptin. ROS generation measurement by chemiluminescence of PMN cells
Outcome measures
| Measure |
Placebo
n=17 Participants
Patients will be treated for 12 weeks with placebo once daily
Placebo
|
Linagliptin 5mg Per Day
n=17 Participants
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Linagliptin
|
|---|---|---|
|
Oxidative Stress (as ROS Generation Level)
Week 0
|
102 mV
Standard Error 13
|
91 mV
Standard Error 8
|
|
Oxidative Stress (as ROS Generation Level)
Week 2
|
95 mV
Standard Error 13
|
85 mV
Standard Error 11
|
|
Oxidative Stress (as ROS Generation Level)
Week 4
|
94 mV
Standard Error 11
|
81 mV
Standard Error 8
|
|
Oxidative Stress (as ROS Generation Level)
Week 12
|
97 mV
Standard Error 10
|
76 mV
Standard Error 8
|
SECONDARY outcome
Timeframe: At baseline and week 12Insulin sensitivity is measured with HE clamp. Glucose Infusion Rate was titrated to maintain blood glucose concentration at the fasting glucose level. Plasma samples for glucose was obtained at 10-minute intervals starting 30 minutes before the clamp, to quantitate rates of whole-body glucose disposal. Difference from baseline at 12 weeks is calculated and compared to placebo arm
Outcome measures
| Measure |
Placebo
n=17 Participants
Patients will be treated for 12 weeks with placebo once daily
Placebo
|
Linagliptin 5mg Per Day
n=17 Participants
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Linagliptin
|
|---|---|---|
|
Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp
Baseline
|
123 mL/hr
Standard Error 21
|
137 mL/hr
Standard Error 22
|
|
Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp
At 12 Weeks
|
119 mL/hr
Standard Error 20
|
141 mL/hr
Standard Error 31
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Linagliptin 5mg Per Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Paresh Dandona, B.Sc., M.B. B.S., D.Phil., F.R.C.P
State University of NY at Buffalo
Phone: 71653518520
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place